Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
NEEDLE GUIDE AND ASSEMBLY THEREOF
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

 
FIELD OF INVENTION
[1] The present disclosure relates to a medical device. More particularly, the present disclosure relates to a needle guide for endo-cavity procedures.
BACKGROUND OF INVENTION
[2] A common medical procedure known as “in vitro fertilization” (IVF) helps a couple to overcome their inability to naturally conceive a baby. In the IVF procedure, one of the essential steps is to retrieve eggs from the ovaries of a female donor. The egg, thereafter, is subjected to fertilization inside a test tube or the like to obtain a zygote (also known as a fertilized egg). The actively dividing zygote is then implanted back into the womb of the female donor (or a female surrogate) for the development of the baby.
[3] The step of retrieving the egg from the female donor's ovaries typically involves administering medication(s) to stimulate the ovaries to produce multiple eggs. Under local sedation or anesthesia, a needle having a fixed length is guided towards the female donor’s ovaries with the help of a transvaginal ultrasound imaging technique. After appropriately positioning the needle, the fluid containing the eggs is gently aspirated with the help of the needle. Thereafter, the retrieved egg is either immediately subjected to fertilization or is refrigerated for later fertilization.
[4] The conventional needle used to retrieve the eggs with the help of a transvaginal ultrasound imaging, presents several challenges. The most common problem associated with the conventional needle is the lack of a tool with the needle to precisely control the depth/penetration of the needle thus, making the procedure cumbersome and difficult. More often than not, the needle is inadvertently over penetrated causing damage to the surrounding tissues while missing the target. The said damage to the tissues may lead to various complications like discomfort, pain, ovarian damage, internal bleeding, and/or infection. To address the said complications, a surgical intervention may be required, for example, a laparoscopic surgery to address internal bleeding, or repair any damaged structures. The surgical intervention adds an unexpected layer of complexity, financial expenses and risk to the female donor’s treatment plan. They not only contribute to physical risk but also increase emotional stress and anxiety of the female donor, who may already be facing the emotional challenges associated with fertility treatments. In rare cases, these complications may have long term implications for any future fertility treatments.
[5] Thus, there arises a need for a device that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[6] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings, however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[7] The present disclosure relates to an assembly including a needle guide, a hub and a needle. The needle guide extending between a proximal end and a distal end. The needle guide including a teethed portion disposed towards the proximal end and extending along a length of the needle guide. The teethed portion including a base, and at least one elongated member defining a plurality of alternating projections and notches. The projections at least partially extend over the base and define a channel. The hub is movably coupled to the teethed portion of the needle guide. The hub including a lower step, a tab, and a wedge. The lower step is configured to be movably disposed within the channel of the teethed portion. The tab is positioned above the lower step and operatively coupled to the alternating projections and notches. The wedge is disposed above the tab and configured to selectively press the tab. The wedge defines a hole. The needle is disposed across the hole of the wedge. The needle has a pre-defined length. The hub is configured to be toggled between a locked state and an unlocked state by selectively pressing the wedge. In the locked state, the tab is disposed between two adjacently disposed projections and within one notch, thereby arresting the position of the hub within the teethed portion. In the unlocked state, the tab is disposed at least partially in the channel of the teethed portion, thereby enabling the hub to move along a length of the teethed portion and adjust a length of the needle that is exposed out of the needle guide by either pushing or pulling the wedge.
BRIEF DESCRIPTION OF DRAWINGS
[8] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[9] Fig. 1 depicts a perspective view of an assembly 1 of a needle guide 100, a needle hub 10 and a probe 20, according to an embodiment of the present disclosure.
[10] Fig. 1a depicts an exploded view of the assembly 1, according to an embodiment of the present disclosure.
[11] Fig. 1b depicts the probe 20 of the assembly 1, according to an embodiment of the present disclosure.
[12] Fig. 1c depicts the needle hub 10 of the assembly 1, according to an embodiment of the present disclosure.
[13] Fig. 1d depicts an enlarged view of the hub 13 coupled to a needle 11 of the needle hub 10, according to an embodiment of the present disclosure.
[14] Fig. 1e depicts the hub 13 as depicted in Fig. 1d without the needle 11, according to an embodiment of the present disclosure.
[15] Fig. 1f depicts a proximal view of the needle hub 10, according to an embodiment of the present disclosure.
[16] Fig. 1g depicts an exploded view of the hub 13, according to an embodiment of the present disclosure.
[17] Fig. 1h depicts a perspective view of the needle guide 100 with the needle hub 10, according to an embodiment of the present disclosure.
[18] Fig. 1i depicts a proximal enlarged view of a teethed portion 107 of the needle guide 100, according to an embodiment of the present disclosure.
[19] Fig. 1j depicts a top view of the teethed portion 107 of the needle guide 100, according to an embodiment of the present disclosure.
[20] Fig. 1k depicts an enlarged view of the coupling of the needle hub 10 and the teethed portion 107 of the needle guide 100, according to an embodiment of the present disclosure.
[21] Fig. 1l depicts an enlarged view of the hub 13 in a locked state, according to an embodiment of the present disclosure.
[22] Fig. 1m depicts an enlarged view of the hub 13 in an unlocked state, according to an embodiment of the present disclosure.
[23] Figs. 2a-d depict different positions of the needle hub 10 relative to the teethed portion 107 of the needle guide 100, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[24] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[25] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[26] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[27] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[28] The present disclosure relates to an assembly of a needle guide and a needle hub. The needle hub includes a needle and a hub that is movably coupled to the needle guide. The assembly is used in endo-cavity procedures, for example, egg retrieval procedures during in vitro fertilization (IVF). The assembly may optionally be used along with an integrated or removably coupled ultrasound probe for real-time visualization while navigating and positioning the needle in vivo. The needle guide facilitates precise control over relative position of the needle hub and the needle’s placement during endo-cavity procedures, Precise placement of the needle prevents any damage to the surrounding tissues.
[29] The assembly of the present disclosure enables a medical practitioner to easily move the needle hub along a portion of the needle guide to selectively fine tune the needle’s depth/penetration, i.e., a length of the needle that is exposed out of the needle guide. This significantly minimizes the risk of over-penetration of the needle and associated complications. By keeping the complications at bay, the assembly of the present disclosure not only maintains physical and emotional well-being of a patient undergoing an endo-cavity procedure, it also safeguards the possibility of the patient to undergo future procedures if they wish to. Further, the relative movement between the needle guide and the needle hub allows a medical practitioner to adjust the length of the needle that is exposed out of the needle guide according to the anatomy of individual patients and other clinical scenarios while reducing the risk of trauma and bleeding.
[30] In an exemplary embodiment, the assembly of the present disclosure is a single-use device that is sterilized with ethylene oxide (EtO) gas. In an alternate embodiment, the assembly of the present disclosure is used multiple times by sterilizing the device in-between procedures.
[31] Now, referring to figures, Fig. 1 depicts an exemplary assembly 1 according to an embodiment of the present disclosure. Fig. 1a depicts an exploded view of the assembly 1. The assembly 1 includes without limitation, a needle guide 100, a needle hub 10 and a probe 20. In the depicted embodiment, the needle guide 100 is disposed at least partially between the needle hub 10 disposed at the top, and the probe 20 disposed at the bottom. The entire assembly 1 extends between a proximal end 1a and a distal end 1b. The proximal end 1a and the distal end 1b has been used as a reference to describe all the components of the assembly 1.
[32] The probe 20 is positioned at a bottom end of the assembly 1 and defines a top surface. On the top surface of the probe 20, the needle guide 100 is placed. The probe 20 may be removably coupled underneath the needle guide 100 for real-time visualization (feedback) while advancing and positioning the needle guide 100 inside an endo cavity of an individual. Although the probe 20 is described as being coupled underneath the needle guide 100 as an example, the probe 20 may be coupled to at least one of the sides, or the top of the needle guide 100 and the same is within the scope of the teachings of the present disclosure. Further details of the probe 20 are described with reference to Fig. 1b. The needle hub 10 is described with reference to Figs. 1c-1g. The needle guide 100 and its components are described with reference to Figs. 1h-1j. The coupling between the needle guide 100 and the needle hub 10 to at least partially form the assembly 1 is described with reference to Figs. 1k-1m.
[33] As stated earlier, Fig. 1b depicts the probe 20. The probe 20 has an elongated structure. The probe 20 has a housing made of one or more materials including, but not limited to, polycarbonate (PC), polypropylene (PP), polyvinyl Chloride (PVC), etc. In an embodiment, the housing includes one or more piezoelectric crystals used for generating and receiving sound waves analogous to sonar-based imaging. The one or more piezoelectric crystals are shielded by ceramic elements that are part of the housing. In an exemplary embodiment, the housing of the probe 20 is made of polycarbonate (PC) incorporated with ceramic elements. The probe 20 may be any conventionally available medical probe used for in vivo medical imaging. The probe 20 may at least be one of a transvaginal ultrasound probe (for example made by GE Healthcare , Philips Healthcare ,Samsung Medison [A2-11ARE, EA2-11AVE, MiniER7]), doppler (for example made by Siemens , GE Healthcare , Philips Healthcare) and 3D/4D ultrasound probe (for example made by GE Healthcare , Philips Healthcare , SonoSite (Fujifilm)), etc. In an exemplary embodiment, the probe 20 is a transvaginal ultrasound probe which enables a medical practitioner to visualize an endo-cavity of an individual and a portion of the needle guide 100 on a display (not shown) connected to the probe 20.
[34] Fig. 1c illustrates the needle hub 10. The needle hub 10 is a sub assembly of a needle 11 provided with a hub 13. The hub 13 is provided towards the proximal end 1a. The needle 11 and the hub 13 may form an integral component or may be separate components fixedly coupled together via at least one of welding, UV light laser curing, etc. Alternatively, the needle 11 may be movably coupled to the hub 13. In an exemplary embodiment, the hub 13 of the needle hub 10 is movably coupled to the needle guide 100.
[35] The needle 11 extends at least partially from the hub 13 to the distal end 1b of the assembly 1. The needle 11 has a pre-defined length. The length of the needle 11 ranges from 100 mm to 250 mm. The diameter of the needle ranges from 1.80 mm (15 gauge) to 0.91 mm (20 gauge). In an exemplary embodiment, the length and diameter of the needle 11 is 170 mm and 1.80 mm (15 gauge) respectively. The needle 11 is made of one or more materials including, but not limited to, medical grade stainless steel, titanium, etc. In an exemplary embodiment, the needle 11 is made of medical grade stainless steel. The needle 11 has a lateral cross-sectional shape including, but not limited to, circular, oval, etc. In an exemplary embodiment, the lateral cross-sectional shape of the needle 11 is circular.
[36] The needle 11 includes a lumen (not shown) along its entire length. The lumen of the needle 10 allows passage of bodily fluids or the like through the needle 11. For example, the needle 10 may be used to collect fluid/cells from within an endo-cavity of an individual via the lumen. Alternately, the needle 11 may be used to penetrate one or more tissues.
[37] Additionally, or optionally, the distal end 1b of the needle 11 includes a tip having a pre-defined shape including, but not limited to, beveled-tip, round tip, blunt tip, curved tip, straight tip, etc. In an exemplary embodiment, the distal end 1b of the needle 11 includes a beveled-tip. The beveled-tip helps to better penetrate tissues, if required.
[38] Fig. 1d depicts an enlarged proximal portion of the needle hub 10. Additionally, or optionally, as shown in Fig. 1d, the needle 11 is provided with a tail 11a at the proximal end 1a. The tail 11a may have a pre-defined shape including, but not limited to, conical, tapered, rounded, circular, etc. In an exemplary embodiment, the shape of the tail 11a is conical. The maximum diameter of the tail 11a is larger than the diameter of the needle 11. Due to this, the needle 10 is prevented from inadvertently sliding away from the hub 13 (described later). The tail 11a may be used to connect other medical devices/tool, for example, an aspirator/vacuum source to aspirate bodily fluids or the like during an endo-cavity procedure.
[39] Although the assembly 1 is described with the example of the needle 11, other functionally equivalent components like stylet, cannula, etc. may be used instead and the same are within the scope of the teachings of the present disclosure.
[40] As shown in Figs. 1c and 1d, the hub 13 is coupled to the proximal portion of the needle 11. Different perspective views of the hub 13 are depicted in Figs. 1e, 1f, and 1g. The hub 13 includes a stepped structure of a block with a wedge 13a. The block includes an upper step 13b, and a lower step 13c. The upper step 13b and the lower step 13c coupled to each other via two side walls 13d. The wedge 13a, and the block may be fixedly coupled to each other (for example, by welding, UV light laser curing, etc.) or may be formed as an integral unit. In an exemplary embodiment, the wedge 13a, and the block are formed integrally as a single unit.
[41] The wedge 13a, and the block are made of one or more materials including, but not limited to, polycarbonate (PC), polyvinyl chloride (PVC), acrylonitrile butadiene styrene (ABS), etc. In an exemplary embodiment, the wedge 13a, and the block are made of polycarbonate (PC) and acrylonitrile butadiene styrene (ABS) respectively. The block has a length ranging from 12 mm to 20 mm. The block has a width ranging from 8 mm to 12 mm. In an exemplary embodiment, the length and width of the block is 15 mm and 10 mm respectively.
[42] The wedge 13a is the topmost portion of the hub 13 and is disposed above the upper step 13b (and the lower step 13c). The wedge 13a provides a surface for the medical practitioner to interact and/or move the hub 13 along a length of the needle guide 100. The wedge 13a may have any ergonomic shape that allows the medical practitioner to easily and comfortably interact with the hub 13. The shape of the wedge 13a includes, without limitation, trapezoidal, square, round, rectangle, etc. In an exemplary embodiment, the wedge 13a has a trapezoidal shape with increasing height from the distal end 1b to the proximal end 1a. The maximum height of the wedge 13a ranges from 5 mm to 10 mm. The wedge 13a may have a length less than or equal to the length of the hub 13. In an exemplary embodiment, the maximum height and length of the wedge 13a is 7 mm and 13 mm respectively. The wedge 13a has a width ranging from 8 mm to 12 mm. In an exemplary embodiment, the width of the wedge 13a is 10 mm.
[43] As shown in Fig. 1e, the wedge 13a defines a hole 13a1 configured to receive the needle 11. In other words, the needle 11 is disposed across the hole 13a1 of the wedge 13a. The hole 13a1 extends along the entire length of the wedge 13a. The hole 13a1 has a pre-defined diameter that is more than the diameter of the needle 11 but less than the diameter of the distal end of the tail 11a.
[44] The block may be a solid body having side walls and one or more carvings and/or extensions. For example, the block includes the upper step 13b disposed beneath the wedge 13a. The upper step 13b has a pre-defined shape including, but not limited to, square, round, rectangle, trapezoidal, etc. In an exemplary embodiment, as shown in Fig. 1d, the upper step 13b is square-shaped.
[45] The lower step 13c is disposed beneath the upper step 13b and coupled thereto via at least two side walls 13d. The lower step 13c may be structurally and dimensionally identical or different from the upper step 13b. In an exemplary embodiment, the lower step 13c is structurally and dimensionally identical to the upper step 13b. In the depicted embodiment, the lower step 13c and the upper step 13b are co-aligned.
[46] As shown in Fig. 1e, the side wall 13d and portions of the respective upper step 13b and the lower step 13c define at least one passage 13e. The passage 13e extends from the proximal end 1a to the distal end 1b of the hub 13. In the depicted embodiment, the hub 13 includes two passages 13e provided at respective sides extending between the proximal end 1a and the distal end 1b.
[47] Each of the walls 13d define a slot 13d1 to at least partially receive a plate 13f (also depicted in Fig. 1g). The slot 13d1 of the wall 13d disposed at the distal end 1b is depicted in Fig. 1e. Fig. 1f depicts a rear view of the hub 13 as viewed from the proximal end 1a. The slot 13d1 of the wall 13d disposed at the proximal end 1a is depicted in Fig. 1f. The slots 13d1 of the two walls 13d are at least partially co-aligned with each other. A portion of the plate 13f is fixedly coupled to the slots 13d1 via at least one of welding, adhesives, UV curing, etc. In an exemplary embodiment, the two ends of the plate 13f is coupled to the respective slots 13d1 of the two side walls 13d via UV curing.
[48] Fig. 1g depicts an exploded view of the hub 13. As shown in Figs. 1e and 1f, a tab 13g is disposed at least partially within the passage 13e. The tab 13g is made of one or more material including, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polypropylene (PP), polyetherimide (Ultem), polytetrafluorethylene (PTFE), stainless steel (SS). In an exemplary embodiment, the tab 13g is made of polyvinyl chloride (PVC). The tab 13g includes a pre-defined lateral cross-sectional shape including, but not limited to, Omega (Ω)-shaped, C-shaped, U-shaped, etc. In an exemplary embodiment, as shown in Fig. 1g, the shape of the tab 13g is substantially Omega (Ω)-shaped.
[49] As shown in Fig. 1g, the side wall 13d along with the portion of the upper step 13b and the lower step 13c defines a cavity 13h therebetween. The cavity 13h has a pre-defined shape including, but not limited to, Omega(Ω)-shaped, C-shaped, U-shaped, etc. In an exemplary embodiment, the cavity 13h is substantially Omega (Ω)-shaped.
[50] The tab 13g is disposed laterally across the cavity 13h such that the tab 13g at least partially extends from within the cavity 13h to the two passages 13e (as shown in Fig. 1f). The wedge 13a is disposed above the tab 13g. The tab 13g is disposed under the upper step 13b. And, the tab 13g is disposed above the lower step 13c. An upper surface of the tab 13g is configured to at least partially abut a bottom surface of the upper step 13b.
[51] As shown in Fig. 1g, the plate 13f extends axially within the cavity 13h between the two walls 13d. The plate 13f is made of one or more materials, including but not limited to, stainless steel, Titanium, copper, cobalt chromium, polytetrafluorethylene (PTFE) polytheretherketone (PEEK), etc. In an exemplary embodiment, the plate 13f is made of stainless steel. The plate 13f has a width that is either equal to or less than the width of the walls 13d. In an exemplary embodiment, the width of the plate 13f is less than the width of the walls 13d. The plate 13f has a thickness ranging from 0.2 mm to 1.0 mm. In an exemplary embodiment, the thickness of the plate 13f is 0.4 mm.
[52] As shown in Fig. 1g, a bottom surface of the tab 13g has an indent 13g1 at the center. The indent 13g1 of the tab 13g is disposed above a portion of the plate 13f and coupled thereto via at least one of slot fit, snap fit, press fit, interference fit, tension fit, etc. In an exemplary embodiment, the tab 13g is coupled to the plate 13f by slot fit. The width of the indent 13g1 is equal to the width of the plate 13f. The indent 13g1 prevents the tab 13g to slide out the hub 13 from over the plate 13f.
[53] Fig. 1h depicts the needle hub 10 coupled to the needle guide 100. The needle guide 100 includes a body 100a having two edges 101, at least two wings 103, a cover 105 and a teethed portion 107. The needle guide 100 is made of one or more materials including, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polypropylene (PP), polyetherimide (Ultem), polytetrafluorethylene (PTFE), stainless steel (SS), etc. In an exemplary embodiment, the needle guide 100 is made of acrylonitrile butadiene styrene (ABS). The needle guide 100 includes an elongated structure for easy advancement through the endo-cavities of an individual. However, other functionally equivalent structures of the needle guide 100 like a cuboid, etc. are within the scope of the teachings of the present disclosure.
[54] The length of the needle guide 100 may range between 100 mm to 350 mm that allows for effective reachability and positioning of the needle 11 during endo-cavity procedures. In an exemplary embodiment, the length of the needle guide 100 is 300 mm which allows for effective reach and positioning of the needle 11 of the needle hub 10 within the endo-cavity. The width of the needle guide 100 may correspond to the width of the probe 20.
[55] As shown in Fig. 1h, the body 100a of the needle guide 100 defines the two edges 101 extending between the proximal end 1a and the distal end 1b. Additionally or optionally, the edges 101 of the needle guide 100 may curve and extend towards a bottom end of the assembly 1 thereby defining a space to removably receive the probe 20. The edges 101 may extend up to a pre-defined height/depth of the probe 20 depending upon the probe 20 used with the guide 100. The edges 101 prevent relative lateral movement between the probe 20 and the guide 100.
[56] Each of the edges 101 of the needle guide 100 is provided with the at least one wing 103. In an exemplary embodiment, as shown in Fig. 1i, the needle guide 100 is provided with two wings 103, one at each of the edges 101. The wings 103 extends along a portion of the length of the needle guide 100, thereby defining a length of the wings 103. The length of the wings 103 ranges from 80 mm to 200 mm. The wings 103 has a height ranging from 15 mm to 30 mm. In an exemplary embodiment, the wings 103 are disposed towards the distal end 1b of the needle guide 100. In an exemplary embodiment, the length and height of the wing 103 is 100 mm and 18 mm, respectively.
[57] The wings 103 are configured to removably receive the probe 20 underneath the needle guide 100. The coupling between the needle guide 100 and the probe 20 prevents any relative movement between the probe 20 and the needle guide 100. The coupling between the needle guide 100 and the probe 20 allows the medical practitioner to have better hand-eye coordination while advancing and positioning the needle hub 10 (and the needle guide 100).
[58] Additionally, or optionally, the wings 103 on either edges 101 of the body 100a are elastically biased towards each other. The said bias helps the wings 103 to firmly grasp the probe 20, when the probe 20 is placed between the wings 103.
[59] The wings 103 may either be removably coupled to the needle guide 100 or are integrally formed with the needle guide 100. In an exemplary embodiment, the wings 103 are integrally formed with the needle guide 100. The wings 103 may have a pre-defined shape including, but not limited to, U-shaped, V-shaped, C-shaped, Omega (Ω)-shaped, etc. In an exemplary embodiment, as shown in Fig. 1h, the wings 103 are elongated U-shaped. The wings 103 are made of one or more materials including, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polypropylene (PP), polyetherimide (Ultem), polytetrafluorethylene (PTFE), stainless steel (SS), etc. In an exemplary embodiment, the wings 103 are made of acrylonitrile butadiene styrene (ABS).
[60] Additionally or optionally, an inner surface of the wings 103 includes a plurality of teeth-like projections (or teeth) 103a (as shown in Fig. 1h). The teeth 103a of the two wings 103 extend towards each other, to hold the probe 20 in the wings 103 via interference fit, press fit, or snap fit. Other functionally equivalent structure may be used to couple the probe 20 to the wings 103 and the same is within the scope of the teachings of the present disclosure. The number of teeth 103a may range between three to nine, arranged in a pre-defined pattern. The number of teeth 117 may vary depending upon the structure of the probe 20. The teeth 103a may be equally spaced or randomly spaced with respect to each other. In an exemplary embodiment, each of the wings 103 includes six equally spaced teeth 103a arranged linearly along the length of the wings 103. The wings 103 along with the teeth 103a helps to retro-fit any conventionally available probe 20 to the needle guide 100.
[61] The cover 105 is disposed towards the distal end 1b of the needle guide 100. The cover 105 extends at least partially from the teethed portion 107 to the distal end 1b of the needle guide 100 (as shown in Fig. 1h). Alternatively, not shown, the cover 105 may be disposed underneath or at either edge 101 of the needle guide 100. The cover 105 is either removably coupled or integrally formed with the needle guide 100. In an exemplary embodiment, the cover 105 is integrally formed with the needle guide 100.
[62] The length of the cover 105 ranges from 80 mm to 160 mm. The width of the cover 105 is less than or equal to the width of the needle guide 100. In an exemplary embodiment, the length of the cover 105 is 150 mm.
[63] The cover 105 defines a lumen 105a extending along the entire length of the cover 105. The lumen 105a allows the needle 11 of the needle hub 10 to extend across the length of the cover 105 and protrude out of the needle guide 100 towards the distal end 1b.
[64] Although the cover 105 is described as a solid body defining a lumen 105a therein, the cover (not shown) may be a hollow body with two holes defined at either ends of the cover and the same is within the scope of the teachings of the present disclosure.
[65] Towards the proximal end 1a, the body 100a defines the teethed portion 107 extending at least partially along the length of the needle guide 100. In an exemplary embodiment, as shown in Fig. 1i, the teethed portion 107 extends from the proximal end 1a of the needle guide 100 to the proximal end of the cover 105. The length of the teethed portion 107 ranges from 40 mm to 100 mm. In an exemplary embodiment, the length of the teethed portion 107 is 60 mm. The teethed portion 107 is made of one or more materials including, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polypropylene (PP), polyetherimide (Ultem), polytetrafluorethylene (PTFE), stainless steel (SS), etc. In an exemplary embodiment, the teethed portion 107 is made of acrylonitrile butadiene styrene (ABS).
[66] Fig. 1i depicts an enlarged portion of the teethed portion 107 as observed from the proximal end 1a of the needle guide 100. The teethed portion 107 includes a base 107a, and at least one elongated member 107b extending along the length of the base 107a. In an exemplary embodiment, the base 107a is disposed between two elongated members 107b. The base 107a has a width ranging from 12 mm to 25 mm. In an exemplary embodiment, the width of the base is 20 mm.
[67] The elongated member 107b has a height ranging from 4 mm to 7 mm. In an exemplary embodiment, the height of the elongated member 107b is 6 mm. As shown in Fig. 1i, each of the elongated members 107b defines a plurality of alternating projections 107b1 and notches 107b2. The projections 107b1 and the notches 107b2 of one elongated member 107b are aligned with the projections 107b1 and the notches 107b2 of the other elongated member 107b. The number of projections 107b1 and notches 107b2 depends upon the length of the teethed portion 107.
[68] The projections 107b1 at least partially extend over the base 107a of the teethed portion 107 as overhangs. The projections 107b1 may have a pre-defined shape including, but not limited to, cuboids, rectangular prism, square prism, trapezoidal prism, oblong prism, etc. In an exemplary embodiment, the projections 107b1 are cuboids. The projections 107b1 has a pre-defined thickness ranging from 2 mm to 5 mm. In an exemplary embodiment, the thickness of the projection 107b1 is 3 mm. The width of the projection 107b1 ranges from 8 mm to 12 mm. In an exemplary embodiment, the width of the projection 107b1 is 10 mm. The length of the projection 107b1 ranges from 3 mm to 10 mm. In an exemplary embodiment, the length of the projection 107b1 is 5 mm. The length of the projections 107b1 defines the minimum incremental length with which the needle hub 10 (and the needle 10) may be moved within the teethed portion 107.
[69] Between the projection 107b1 and the base 107a, a channel is defined. The thickness of the channel ranges from 2 mm to 5 mm. In an exemplary embodiment, the thickness of the channel is 3 mm.
[70] The distance between two adjacently disposed projections 107b1 on one elongated member 107b defines one notch 107b2. The notch 107b2 may have a pre-defined shape including, but not limited to, U-shape, V-shaped, C-shaped, Omega (Ω)-shaped, etc. In an exemplary embodiment, the notch 107b2 is U-shaped. The width of the notch 107b2 ranges from 6 mm to 9 mm. The depth of the notch 107b2 ranges from 3 mm to 6 mm. In an exemplary embodiment, the width and depth of the notch 107b2 are 8 mm and 5 mm respectively. The notch 107b2 is configured to selectively capture the tab 13g of the hub 13, thereby selectively arresting the position of the hub 13 of the needle hub 10 along the length of the teethed portion 107.
[71] Fig. 1j depicts a top view of the teethed portion 107. Additionally, or optionally, at least one projections 107b1 are provided with a graduation mark 107c. The graduation marks 107c indicate either the length of the teethed portion 107 or the length of a portion of the needle 11 of the needle hub 10 that is exposed out of the lumen 105a of the cover 105 towards the distal end 1b (described below).
[72] In an exemplary embodiment, as shown in Fig. 1j, the graduation marks 107c include three markings as ‘1’, ‘2’, and ‘3’ embossed/painted on the projections 107b1 at one of the two elongated members 107b. The markings are placed 15 mm apart from each other. Additionally or optionally, the graduation marks 107c may be color-coded for easy identification of the graduation marks 107c during the endo-cavity procedure. In an exemplary embodiment, the marking ‘1’ is coded with yellow color, the marking ‘2’ is coded with green color, and the marking ‘3’ is coded with red color.
[73] Now the coupling between the hub 13 of the needle hub 10 and the teethed portion 107 of the needle guide 100 will be described with reference to Fig. 1k. The hub 13 is movably coupled to the teethed portion 107 of the needle guide 100. At least a portion of the lower step 13c of the hub 13 is configured to be movably disposed within the channel defined by the projections 107b1 and the base 107a. The projections 107b1 on either side of the teethed portion 107, are at least partially disposed within the passage 13e of the hub 13. The wedge 13a of the hub 13 is configured to protrude out of the teethed portion 107, thereby enabling a medical practitioner to grasp/press/push the wedge 13a and move the hub 13 across the length of the teethed portion 107. The tab 13g is operatively coupled to the alternating projections 107b1 and notches 107b2 of the teethed portion 107.
[74] Although the depicted embodiment of assembly 1 of the present disclosure is described with two elongated members 107b of the teethed portion 107 and two corresponding passages 13e of the hub 13, an assembly (not shown) may include only one elongated member of the teethed portion and correspondingly only one passage of the hub. The same is within the scope of the teachings of the present disclosure.
[75] Additionally, or optionally, the proximal end 1a of the teethed portion 107 is closed with the help of a cap 107d or the like. The cap 107d is made of one or more materials including but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polypropylene (PP), polyetherimide (Ultem), polytetrafluorethylene (PTFE), stainless steel (SS), etc. In an exemplary embodiment, the cap 107d is made of acrylonitrile butadiene styrene (ABS). The cap 107d may have a pre-defined shape including, but not limited to, rectangle, square, parallelogram, trapezoid, cuboid, etc. In an exemplary embodiment, the shape of the cap 107d is rectangle. The cap 107d may be coupled to the teethed portion 107 via at least one of snap fit, tolerance fit, slot fit, etc. The cap 107d is at least partially disposed between a portion of one projection 107b1 and a portion of the base 107a. In an exemplary embodiment, the cap 107d is coupled to the teethed portion 107 with the help of snap fit.
[76] The hub 13 is configured to be toggled between two states, namely, a locked state and an unlocked state. The hub 13 in its natural state, is in the locked state. The medical practitioner may selectively press the wedge 13a of the hub 13 to toggle the hub 13 from its locked state to its unlocked state. Upon depressing the wedge 13a, the hub 13 is configured to self-toggle to its locked state if the tabs 13g of the hub 13 are disposed between two adjacent projections 107b1, i.e., within the notch 107b2.
[77] Figs. 1k and 1l depict the hub 13 in its locked state. The tab 13g of the hub 13 is disposed between two adjacently disposed projections 107b1 and within the notch 107b2 of the elongated member 107b. In the locked state of the hub 13, the tab 13g is configured to at least partially protrude out of the notch 107b2 (i.e., between two adjacent projections 107b1), thereby preventing the hub 13 to move along the length of the teethed portion 107. In other words, the position of the hub 13 is arrested within the teethed portion 107.
[78] To toggle the hub 13 from its locked state to the unlocked state (as shown in Fig. 1m), the medical practitioner presses the wedge 13a which triggers the upper step 13b to flex and push/press on the tab 13g against the plate 13f, causing the plate 13f to flex. Pressing the tab 13g causes the tab 13g to be pushed below the projections 107b1 and disposed at least partially in the channel of the teethed portion 107. In the unlocked state, the tab 13g is free to move through the channel defined between the projection 107b1 and the base 107a. In this manner, until the wedge 13a of the hub 13 is depressed, the medical practitioner may move the hub 13 along the length of the teethed portion 107 by either pushing or pulling the wedge 13a of the hub 13 and adjust a length of the needle 11 that is exposed out of the needle guide 100.
[79] To toggle the hub 13 from its unlocked state to the locked state, the tab 13g is first positioned within one of the notches 107b2 of the teethed portion 107 and the wedge 13a is depressed. Depressing the wedge 13a of the hub 13 triggers the plate 13f to straighten and push the tab 13g above such that the tab 13g is arrested between two projections 107b1 (i.e., within one notch 107b2) and the movement of the hub 13 relative to the teethed portion 107 is arrested.
[80] The medical practitioner, by using the locked and unlocked states of the hub 13, accurately repositions the needle hub 10 and precisely control the needle’s 10 depth/penetration (i.e., the length of the needle 11 that is exposed out of the needle guide 100). In other words, the medical practitioner based on the requirements of the endo-cavity procedure, selectively presses the wedge 13a and moves the hub 13 to control the depth/penetration of the needle 11. While moving the hub 13 across the length of the teethed portion 107, the medical practitioner may take note of the position of the hub 13 relative to the graduation marks 107c. The relative position of the hub 13 relative to the graduation marks 107c enables the medical practitioner to accurately determine the depth/penetration of the needle 11.
[81] For example, when the hub 13 is disposed at a proximal-most end of the teethed portion 107 (as shown in Fig. 2a), the needle 11 does not protrude out of the lumen 105a of the cover 105. In other words, a distalmost end of the needle 11 is completely within the lumen 105a of the cover 105. Concealing the distalmost tip of the needle 11 ensures atraumatic insertion of the needle guide 100 within the endo-cavity and precise positioning of the needle guide 100 therein.
[82] When the hub 13 is disposed proximal to the graduation mark 107c with marking ‘1’, the needle 11 at least partially emerges towards the distal end 1b. As shown in Fig. 2b, the needle 11 emerges out of the lumen 105a of the cover 105 but not beyond a distalmost end of the probe 20. Preventing the needle 11 to extend beyond the distalmost end of the probe 20, ensures that the needle 11 does not come in contact with the walls of the endo-cavity during the endo-cavity procedure enabling the medical practitioner to accurately control and navigate the needle guide 100 within the endo-cavity. In an exemplary embodiment, the position of the hub 13 proximal to the marking ‘1’ represents that the depth/penetration of the needle 11 is less than 5 mm.
[83] When the hub 13 is disposed proximal to the graduation mark 107c with marking ‘2’, the needle 11 at least partially emerges towards the distal end 1b and beyond the distalmost end of the probe 20. As shown in Fig. 2c, the needle 11 emerges out of the lumen 105a of the cover 105 such that the medical practitioner may contact the needle 11 to, for example, the ovarian tissue (not shown). In an exemplary embodiment, the position of the hub 13 proximal to the marking ‘2’ represents that the depth/penetration of the needle 11 is less than 15 mm.
[84] The notches 107b2 disposed between the graduation markings 107c with markings ‘1’ and ‘2’ allow the medical practitioner to incrementally increase (or decrease) the depth/penetration of the needle 11. The ability to incrementally increase and precisely control the depth/penetration of the needle 11, thereby enabling the medical practitioner to target the ovarian tissue accurately. The incremental increase in depth/penetration of the needle 11 provides confidence to the medical practitioner which in turn safeguards the physical and mental interests of the individual undergoing the endo-cavity procedure. In an exemplary embodiment, the notches 107b2 between the markings ‘1’ and ‘2’ allows the medical practitioner to incrementally increase the depth/penetration of the needle 11 from 5 mm, to 10 mm, and to 15 mm.
[85] When the hub 13 is disposed proximal to the graduation mark 107c with marking ‘3’, the needle 11 at least partially emerges towards the distal end 1b and beyond the distalmost end of the probe 20. As shown in Fig. 2d, the needle 11 emerges out of the lumen 105a of the cover 105 such that the medical practitioner may contact the needle 11 to, for example, the ovarian tissue (not shown). In an exemplary embodiment, the position of the hub 13 proximal to the marking ‘3’ represents that the depth/penetration of the needle 11 is less than 30 mm.
[86] The pair of notches 107b2 disposed between the graduation markings 107c with marking ‘2’ and ‘3’ allows the medical practitioner to incrementally increase (or decrease) the depth/penetration of the needle 11. The ability to incrementally increase and precisely control the depth/penetration of the needle 11, thereby enabling the medical practitioner to target the ovarian tissue accurately. The incremental increase in depth/penetration of the needle 11 allows accurate therapeutic outcomes as intended while minimizing the risk of inadvertent tissue damage. In an exemplary embodiment, the notches 107b2 between the markings ‘2’ and ‘3’ allows the medical practitioner to incrementally increase the depth/penetration of the needle 11 from 20 mm, to 25 mm, and to 30 mm.
[87] Accordingly, the medical practitioner selectively depresses the wedge 13a to arrest the movement of the hub 13 (thereby, the needle 11). Depending upon the position of the hub 13 relative to the graduation marks 107c where the wedge 13a is depressed, the depth/penetration of the needle 11 is fixed by the medical practitioner based on the endo-cavity procedure.
[88] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM,
1. An assembly (1) comprising:
a. a needle guide (100) extending between a proximal end (1a) and a distal end (1b), the needle guide (100) including a teethed portion (107) disposed towards the proximal end (1a) and extending along a length of the needle guide (100), the teethed portion (107) including:
i. a base (107a), and
ii. at least one elongated member (107b) defining a plurality of alternating projections (107b1) and notches (107b2), the projections (107b1) at least partially extend over the base (107a) and define a channel;
b. a hub (13) movably coupled to the teethed portion (107) of the needle guide (100), the hub (13) including:
i. a lower step (13c) configured to be movably disposed within the channel of the teethed portion (107),
ii. a tab (13g) positioned above the lower step (13c) and operatively coupled to the alternating projections (107b1) and notches (107b2), and
iii. a wedge (13a) disposed above the tab (13g) and configured to selectively press the tab (13g), the wedge (13a) defining a hole (13a1); and
c. a needle (11) disposed across the hole (13a1) of the wedge (13a), the needle (11) having a pre-defined length;
wherein, the hub (13) is configured to be toggled between a locked state and an unlocked state by selectively pressing the wedge (13a);
wherein, in the locked state, the tab (13g) is disposed between two adjacently disposed projections (107b1) and within one notch (107b2), thereby arresting the position of the hub (13) within the teethed portion (107); and
wherein, in the unlocked state, the tab (13g) is disposed at least partially in the channel of the teethed portion (107), thereby enabling the hub (13) to move along a length of the teethed portion (107) and adjust a length of the needle (11) that is exposed out of the needle guide (100) by either pushing or pulling the wedge (13a).
2. The assembly (1) as claimed in claim 1, wherein the needle guide (100) is removably coupled to a probe (20).
3. The assembly (1) as claimed in claim 1, wherein the needle guide (100) defines two edges (101), each of the edges (101) provided with at least one wing (103) provided with a plurality of teeth (103a).
4. The assembly (1) as claimed in claim 1, wherein a cover (105) defining a lumen (105a) is disposed towards the distal end (1b) of the needle guide (100).
5. The assembly (1) as claimed in claim 4, wherein the needle (11) extends at least partially across the lumen (105a) of the cover (105).
6. The assembly (1) as claimed in claim 1, wherein at least one of the projections (107b1) is provided with a graduation mark (107c).
7. The assembly (1) as claimed in claim 1, wherein the hub (13) includes a stepped structure of a block, the block includes an upper step (13b) and the lower step (13c) coupled to each other via two side walls (13d).
8. The assembly (1) as claimed in claim 7, wherein the tab (13g) is disposed above a plate (13f), the plate (13f) disposed within a cavity (13h) defined at least by the upper step (13b) and the lower step (13c).
9. The assembly (1) as claimed in claim 7, wherein the side wall (13d) and portions of the respective upper step (13b) and the lower step (13c) define at least one passage (13e).
10. The assembly (1) as claimed in claim 7, wherein the tab (13g) is at least partially within the passage (13e).
11. The assembly (1) as claimed in claim 7, wherein the projections (107b1) are at least partially disposed within the passage (13e).
12. The assembly (1) as claimed in claim 1, wherein the length of the projections (107b1) ranges from 3 mm to 10 mm.
13. The assembly (1) as claimed in claim 1, wherein a lateral cross-sectional shape of the tab (13g) is one of Omega (Ω)-shaped, C-shaped, or U-shaped.